GE Healthcare, LLC Centricity Enterprise Web Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Centricity Enterprise Web
Brand
GE Healthcare, LLC
Lot Codes / Batch Numbers
Software Versions 3.0 through 3.0 SP14d, 4.0 through 4.0 Spa6c and 4.0 Spa7b, Codes: 2027870-0XX, 2049944-0XX, 2068692-0XX.
Products Sold
Software Versions 3.0 through 3.0 SP14d, 4.0 through 4.0 Spa6c and 4.0 Spa7b; Codes: 2027870-0XX, 2049944-0XX, 2068692-0XX.
GE Healthcare, LLC is recalling Centricity Enterprise Web due to Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distanc. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy images that are scaled down from their original resolution.
Recommended Action
Per FDA guidance
GE Healthcare notified consignees on about 04/28/2022 via letter titled "URGENT MEDICAL DEVICE CORRECTION." The letter outlined two safety issues and instructed customers to continue to use the device in accordance with the User Manuals, but for issue #1, do not rely on measurements displayed in the viewer. They should manually calibrate the image to create a measurement calibration reference and then perform necessary measurements. For issue #2, do not perform measurements on lossy images. In both instances, customers were requested to complete and return the acknowledgment form to Recall.85460@ge.com. A second letter was sent to customers on about 02/24/2023, to provide instructions for downloading the user manual addendum for CWeb.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026